Self-efficacy and Well-being of Patients With Fibrotic Interstitial Lung Disease

Quality of Life Clinical Trial

Official title:

Self-efficacy and Well-being of Patients With Fibrotic Interstitial Lung Disease - an Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06027333
• Other study ID #: BernerRehaZentrum
• Status: Recruiting
• Start date: November 8, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: March 2024
• Source: Berner Reha Zentrum AG
• Contact: Thimo Marcin, PhD
• Phone: +41 33 244 30 48
• Email: t.marcin[@]rehabern.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients with fibrotic insterstitial lung disease (ILD) participating in inpatient rehabilitation or in outpatient pulmonary care will be invited to participate in this observational study. Patients will fill out questionnaire regarding quality of life and symptoms at baseline and follow-up (at the end of rehabilitation or after the second outpatient ILD consultation). Additionally, clinical data obtained in clinical routine or for the IIP registry will be used for this project. The aim is to assess changes in self-efficacy and quality of life over time and to establish a control cohort for a later feasibility study on a educational and self-management intervention (currently in planning).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria are:

• For Berner Reha Zentrum only: Diagnosis of a FILD as major indication for pulmonary rehabilitation
• For Inselspital only: Enrolled in Idiopathic interstitial Pneumonia (IIP) cohort study (Nr. 246/15 / PB_2016-01524) and agreed to further use of data for further research purpose
• Age = 18 years
• Written informed consent

Exclusion criteria are:

• Cognitive inability or insufficient knowledge of project language (German) to follow informed consent or study procedures
• Sarcoidosis

Related Conditions & MeSH terms

• Fibrotic Lung Disease
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Patient Education
• Quality of Life
• Self Efficacy
• Self-management

Intervention

Behavioral:
• inpatient rehabilitation
This is an uncontrolled observational study on patients undergoing usual care in pulmonary rehabilitation and care

Locations

Country	Name	City	State
Switzerland	Berner Reha Zentrum, Rehabilitation & Sports Medicine, Insel Group, University Hospital Berne	Bern	Heiligenschwendi
Switzerland	Department of Pulmonary Medicine, Inselspital, Bern University Hospital, University of Bern	Bern

Sponsors (4)

Lead Sponsor	Collaborator
Berner Reha Zentrum AG	Insel Gruppe AG, University Hospital Bern, University of Zurich, Zurich University of Applied Sciences

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Self-efficacy	Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool	From t0 to t2 (60-120 days after t0)
Secondary	Change in Self-efficacy	Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool	From t0 to t1 (14-40 days after t0)
Secondary	Change in health related quality of life	King's Brief Interstitial Lung Disease (K-BILD) health status questionnaire,	From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
Secondary	Change in functional status	King's Brief Interstitial Lung Disease (K-BILD) health status questionnaire,	From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
Secondary	Change in self-reported health status	EQ-VAS Score [0 -100] (worst to best health status)	From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
Secondary	Change in self-reported symptoms	Leicester Cough Questionnaire	From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
Secondary	Change in self-reported anxiety and depression	Hospital Anxiety and Depression Scale [0-21] (high number indicates high symptoms)	From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
Secondary	Symptom Visual Analog Scales	Visual Analog Scales [0-100] for Cough, Dyspnoea, Fatigute, Emotions to self-report severity, impairement and self-efficacy in symptom management. (100 means high severity, high impairment and high self-efficacy)	From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
Secondary	Supplemental oxygen needs for activity and at rest	routinely collected data	t0, t1 (14-40 days after t0) and t2 (60-120 days after t0)
Secondary	Re-hospitalization and survival	routinely collected data	from t0 to t2 (60-120 days after t0)